Nutrition, HealthyMAPSNCT05401591
Microalgae as an Alternative Protein Source in Human Nutrition.
A study testing Protein shake in people with Nutrition, Healthy, run by University of Exeter at 1 site in United Kingdom.
Trial summary
Protein is an essential part of the human diet. But with a growing global population and climate emergency, current sources of dietary protein are unable to continue to sustainably meet the global demand. To ensure future food security, new sustainable protein sources are required. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy
- What is being tested?
- Protein shake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Aug 2021to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18.5 -30 kg/m2
- age 18 - 40 years
- healthy
- non-smoker
Who cannot join
- BMI <18.5 or >30 kg/m2
- smoker
- metabolic disease
- relevant food intolerance
- using medications known to affect metabolism
Trial locations and contacts
1 site in 1 country.
About this study
Protein is an essential part of the human diet. But with a growing global population and climate emergency, current sources of dietary protein are unable to continue to sustainably meet the global demand. To ensure future food security, new sustainable protein sources are required. Microalgae - a group of plant-like single cells - are thought to be a good option due to their sustainable farming methods and naturally high protein content. Long term health benefits of eating microalgae have been seen in humans. However, the time directly following microalgae ingestion has not been well studied but is an important period when considering a protein source. This research will compare the period after ingestion of three preparations and/or types of microalgae to a traditional source of protein.
- Conditions
- Nutrition, Healthy
- Being tested
- Protein shake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein shakeDietary supplement
Participant will drink a protein shake made using each of the four protein types.
| Study group | Role | What they receive |
|---|---|---|
| Milk protein | Active comparator | Not described Receives: Dietary Supplement: Protein shake |
| Whole cell chlorella | Experimental | Not described Receives: Dietary Supplement: Protein shake |
| Cracked cell chlorella | Experimental | Not described Receives: Dietary Supplement: Protein shake |
| Spirulina | Experimental | Not described Receives: Dietary Supplement: Protein shake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma amino acids
Amino acid concentrations measured in participant plasma following the ingestion of protein drinks.
Measured: 5 hours postprandial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start28 Aug 2021
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Queensland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401591
- Sponsor's protocol ID
- 21-07-14-A-01
- Acronym
- MAPS
- Status last verified
- Apr 2024
- First submitted
- 26 May 2022
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microalgae as an Alternative Protein Source in Human Nutrition.
- ClinicalTrials.gov ID
- NCT05401591
- Acronym / sponsor ID
- MAPS / 21-07-14-A-01
- Conditions
- Nutrition, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- The University of Queensland
- Study start
- 28 Aug 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Protein is an essential part of the human diet. But with a growing global population and climate emergency, current sources of dietary protein are unable to continue to sustainably meet the global demand. To ensure future food security, new sustainable protein sources are required. Microalgae - a group of plant-like single cells - are thought to be a good option due to their sustainable farming methods and naturally high protein content. Long term health benefits of eating microalgae have been seen in humans. However, the time directly following microalgae ingestion has not been well studied but is an important period when considering a protein source. This research will compare the period after ingestion of three preparations and/or types of microalgae to a traditional source of protein.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Milk protein | Active comparator | Dietary Supplement: Protein shake |
| Whole cell chlorella | Experimental | Dietary Supplement: Protein shake |
| Cracked cell chlorella | Experimental | Dietary Supplement: Protein shake |
| Spirulina | Experimental | Dietary Supplement: Protein shake |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI 18.5 -30 kg/m2
- age 18 - 40 years
- healthy
- non-smoker
Key exclusion criteria (5 listed)
- BMI <18.5 or >30 kg/m2
- smoker
- metabolic disease
- relevant food intolerance
- using medications known to affect metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protein shakeParticipant will drink a protein shake made using each of the four protein types. | Dietary supplement | Cracked cell chlorella, Milk protein, Spirulina, Whole cell chlorella |
Primary outcome
Plasma amino acids
Time frame: 5 hours postprandial
Amino acid concentrations measured in participant plasma following the ingestion of protein drinks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein shake in people with Nutrition, Healthy, run by University of Exeter at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma amino acids (time frame: 5 hours postprandial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.